FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)
Posted May 07 2011 12:00am
The Allergy Dude found this during his daily searching for information on the internet about asthma. The title above is the FDA's summary calling for information from the 4 manufacturers of LABA products in the U.S. The four products (manufacturer in parenthesis) are Advair (GlaxoSmithKline), Dulera (Merck), Foradil (Novartis), and Symbicort (AstraZeneca). Each company was required to do a phase 4 trial in adults including 11,800 subjects each (!). In addition, GlaxoSmithKline was required to do a trial for 6,200 children with Advair. The total of the five studies is 53,000. The FDA expects to have the results during 2017.
The Allergy Dude's commentary: for perspective, the average phase 3 trial includes about 500-2,000 subjects, depending on the disease state. At least 2 pivotal trials are needed for FDA approval. Then there are smaller phase 1 and phase 2 trials, plus throw in 1 non-pivotal phase 3 trial. The total may be 6,000 subjects. Many phase 3 or 4 trials I have participated in required less than 500 subjects. So every one of these trials in a word will be GIGANTIC. My next word will be EXPENSIVE. My next word will be KILLER MIGRAINE HEADACHE. The Allergy Dude certainly favors safety over efficacy and my previously posts documented my stance on the issue of safety of LABAs. To reinterate, LABAs are safe when used as directed currently by the FDA. The issue then is that with an enormous amount of time, effort, and money, we hope to be reassured that the status quo concerning LABA safety still holds whenever the FDA finally finishes analyzing the data. Let's call it 2018 at the earliest, 7 years out. Staggering.